Randomised Controlled Trial of the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy

Not Applicable

Terminated

• Conditions: Cervical Dystocia
• Interventions: Device: Acupuncture; Device: Sham acupuncture

• Registration Number: NCT02394041
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia.

Secondary objectives:

To demonstrate that acupuncture can:

* reduce morbidity, fetal mortality and duration of childbirth;

* reduce the cost of care, due to diminution of caesarean sections and duration of obstetric labor;

* to evaluate the tolerance.

Detailed Description

In this trial, pregnant women with at least 37 weeks of amenorrhea will be randomized to traditional chinese acupuncture, sham acupuncture, or usual care only.

9 investigator sites will participate to this trial targeting to enrol 2220 patients in total. 1780 subjects will receive acupuncture treatment, either effective treatment or sham, whereas 400 patients will receive usual care only.

Acupuncture therapy consists in stimulations on specific skin points of the abdominal area, which are specific acupuncture points in traditional chinese medicine for the induction of obstetric labor, according to the professional recommendations of the French Acupuncture and Traditional Chinese Medicine College.

Each patient will have a 5-week follow-up in this trial.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-02
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Last Update Submitted: 2015-03-19
• Study First Posted: 2015-03-20
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 142

Inclusion Criteria

• Aged ≥ 18 years
• Signed informed consent
• Woman carrying one foetus only
• at 37 weeks (+/- 2 days) of amenorrhea
• Without contraindication to vaginal delivery

Exclusion Criteria

• Prior history of caesarean section
• Non-cephalic presentation
• Fetal macrosomia
• Multiple pregnancy
• Chronic fetal hypoxia
• Placenta praevia
• Risk of neonatal contamination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture	Acupuncture	The first session of acupuncture treatment will be performed at the inclusion visit, 2 additional acupuncture sessions will be scheduled as 1 session per week for the next 2 weeks. One or more additional session will be performed in the delivery room.
Sham acupuncture	Sham acupuncture	The same as active arm but with sham needles.

Primary Outcome Measures

Name	Time	Method
Caesarean section rate	up to 37 weeks	Rate of caesarean section for cervical dystocia in full-time pregnancies

Trial Locations

Locations (1)

Department of Obstetrics, Hôpital Saint-Cloud; 🇫🇷 Saint-Cloud, Hauts-de-Seine, France